Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331552
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2006-05-30
Brief Title:
Doxorubicin Hydrochloride Liposome Cyclophosphamide and Trastuzumab in Treating Patients With Stage IV Breast Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Phase I - II Study of Doxil In Combination With Daily Oral Cyclophosphamide and Herceptin for Patients With HER-2Neu Positive Disease In Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drugs used in chemotherapy such as doxorubicin hydrochloride liposome and cyclophosphamide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as trastuzumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Giving more than one drug combination chemotherapy together with trastuzumab may be a better way to block tumor growth
Detailed Description:
PRIMARY OBJECTIVES I To determine the optimal tolerated dose of Doxil when given in combination with daily oral cyclophosphamide in patients with stage IV breast cancer Phase I II To determine the efficacy overall clinical response rate of the optimal tolerated dose of Doxil when given in combination with daily oral cyclophosphamide and herceptin for HER2 neu positive patients in patients with stage IV breast cancer Phase II SECONDARY OBJECTIVES I To assess the treatment related toxicity associated with each dose level of this regimen and assess efficacy overall clinical response rate Phase I II To assess the safety treatment related toxicity of the optimal tolerated dose of Doxil when given in combination with daily oral cyclophosphamide and herceptin for HER2 neu positive patients in patients with stage IV breast cancer Phase II III To assess time to progression and overall survival following treatment with Doxil and daily oral cyclophosphamide and herceptin for HER2 neu positive patients Phase II IV To compare the response rate in patients who are heavily pretreated to the response rate in patients who are less heavily pretreated OUTLINE This is a phase I dose-escalation study of pegylated doxorubicin HCl liposome followed by a phase II feasibility study Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1 Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity Some patients with HER2neu 3 disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician After completion of study treatment patients are followed up every 3 months for 2 years every 6 months for 3 years and then annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2010-00798 | None | None | None |